An embedded longitudinal multi-faceted qualitative evaluation of a complex cluster randomized controlled trial aiming to reduce clinically important errors in medicines management in general practice

Abstract

BackgroundThere is a need to shed light on the pathways through which complex interventions mediate their effects in order to enable critical reflection on their transferability. We sought to explore and understand key stakeholder accounts of the acceptability, likely impact and strategies for optimizing and rolling-out a successful pharmacist-led information technology-enabled (PINCER) intervention, which substantially reduced the risk of clinically important errors in medicines management in primary care.MethodsData were collected at two geographical locations in central England through a combination of one-to-one longitudinal semi-structured telephone interviews (one at the beginning of the trial and another when the trial was well underway), relevant documents, and focus group discussions following delivery of the PINCER intervention. Participants included PINCER pharmacists, general practice staff, researchers involved in the running of the trial, and primary care trust staff. PINCER pharmacists were interviewed at three different time-points during the delivery of the PINCER intervention. Analysis was thematic with diffusion of innovation theory providing a theoretical framework.ResultsWe conducted 52 semi-structured telephone interviews and six focus group discussions with 30 additional participants. In addition, documentary data were collected from six pharmacist diaries, along with notes from four meetings of the PINCER pharmacists and feedback meetings from 34 practices. Key findings that helped to explain the success of the PINCER intervention included the perceived importance of focusing on prescribing errors to all stakeholders, and the credibility and appropriateness of a pharmacist-led intervention to address these shortcomings. Central to this was the face-to-face contact and relationship building between pharmacists and a range of practice staff, and pharmacists’ explicitly designated role as a change agent. However, important concerns were identified about the likely sustainability of this new model of delivering care, in the absence of an appropriate support network for pharmacists and career development pathways.ConclusionsThis embedded qualitative inquiry has helped to understand the complex organizational and social environment in which the trial was undertaken and the PINCER intervention was delivered. The longitudinal element has given insight into the dynamic changes and developments over time. Medication errors and ways to address these are high on stakeholders’ agendas. Our results further indicate that pharmacists were, because of their professional standing and skill-set, able to engage with the complex general practice environment and able to identify and manage many clinically important errors in medicines management. The transferability of the PINCER intervention approach, both in relation to other prescribing errors and to other practices, is likely to be high.

Developing a complex intervention to improve prescribing safety in primary care: mixed methods feasibility and optimisation pilot study

“…A strength of this study was the use of quantitative and qualitative methods to give a broader understanding of how changeable this high-risk prescribing was, what the barriers to changing prescribing were and how GPs valued this work, which enabled informed choice of outcome measures and optimisation of the intervention 24 26 27. In addition, the findings supported the design of the trial process evaluation28 29 along with the main trial design.…”

Process evaluation of the data-driven quality improvement in primary care (DQIP) trial: active and less active ingredients of a multi-component complex intervention to reduce high-risk primary care prescribing

“…Important differences were that PINCER targeted a broader range of prescribing topics than DQIP, that it was delivered over 12 weeks by pharmacists, and that it was more standardised in terms of how the pharmacists carried out medication reviews. However, the PINCER process evaluation did not explicitly examine the subcomponents of the intervention [28]. A systematic review of main trial evaluations of pharmaceutical and non-pharmaceutical interventions found evaluations of non-pharmaceutical interventions are significantly less likely to list ‘active ingredients’ (those elements of the intervention intended to lead to change in the outcome, [29], and we have not been able to identify any other process evaluations of cluster-randomised trials of multicomponent complex interventions which have examined the ingredients of complex interventions (although such studies are not easy to find because of poor labelling and reporting of process evaluations more generally) [17, 18].…”

What to give the patient who has everything? A qualitative study of prescribing for multimorbidity in primary care

“…37 Some 'errors' were over-ruled by GPs, however, on the basis of clinical experience of the patient, and there were also concerns about the long-term feasibility of pharmacists working in general practice. 38 Participants in the present study undertook informal case reviews of complicated multimorbid patients with their fellow GPs. Even without the rigorous processes of the MDT, participants benefited from the close proximity, ready availability, and generalist perspective of their colleagues.…”